Jump to main content.

Frequent Questions

Training & Graduation

Submissions

Submissions From Companies That Have Graduated

PBT Profiler

Training & Graduation

What qualifies as "taking training" for the purposes of graduation?
While EPA recognizes that there are many qualified groups that can offer training in these methods, we consider "taking training" as having taken Sustainable Futures hands-on training from EPA or one of the grantees who has worked closely with EPA on Sustainable Futures. An important component of the Sustainable Futures training is gaining an understanding of the concepts, goals, and benefits of the Sustainable Futures Initiative, and of the benefits prescreening chemicals at the research and development stage can provide.

Does an individual or company "graduate?"
A company "graduates." For example, if a trained individual moves to another company, "graduate" status does not travel with the person.

If my company contractor takes training does that count as my company taking training?
No, an individual from the company, not a contractor, must take training before the company will be considered as having taken training. EPA wants a company employee to attend so that the company will understand the scope, applicability, and limitations of the Sustainable Futures risk screening methods and understand the programmatic and administrative issues associated with Sustainable Futures.

If my company has a consultant do the prescreening on chemicals my company submits as PMNs, can those submissions count toward our total needed for graduation?
Yes, those submissions developed by a consultant or contractor can count towards graduation as long as the submissions meet other criteria for graduation. Remember that in order for a company to qualify for graduation a company employee must attend the training.

Do prescreened submissions count towards the five required PMN submissions if they were sent in before we took training?
Yes, prescreened submissions sent in prior to taking training will count towards graduation as long as the submission has been adequately screened and is not regulated.

Does a PMN that was dropped with a non-5(e) SNUR count towards graduation from Sustainable Futures?
No, dropped with a non-5(e) SNUR outcome is considered regulated and will not count towards the total PMN submissions needed to graduate.

Will Low Volume Exemptions (LVEs) count towards graduation from Sustainable Futures?
Yes, Low Volume Exemptions (LVEs) will count towards the total PMN submissions needed as long as they are prescreened and not regulated, and for a low volume exemption "not regulated" means it is granted by EPA.

When a company graduates will they get something in writing from EPA?
Yes, once a company graduates they will receive correspondence from EPA indicating that, by virtue of their participation in Sustainable Futures, and their use of risk screening tools (including the P2 Framework) at R&D, they can now submit a simultaneous TMEA and PMN. When the company submits a combined PMN/TMEA they should add to the submission cover letter that they have graduated from Sustainable Futures and are allowed to submit a combined PMN/TMEA.

Top of Page

Submissions

Why is EPA asking for my company's impressions of the usefulness of the methods?
As explained in the Federal Register Notice announcing the Sustainable Futures Initiative, EPA is considering creating a new Pollution Prevention (P2)-based exemption to TSCA that would make the regulatory relief currently available only to graduates of the Sustainable Futures Initiative available also to any company that prescreens a low hazard, low risk new chemical notice. In order to do this EPA needs to provide evidence that risk screening at R&D results in health and environmental benefits.

What should I include in the summary of the usefulness of the methods?
The summary does not need to be detailed. The summary can be a table or brief text that could be included in the cover letter, in the pollution prevention information on page 11 of the PMN form, or included as an attachment to the submission.

Do I need to run exposure models on a low hazard chemical?
No, you don't need to run exposure models if the chemical is low hazard. Remembering that risk equals hazard multiplied by exposure, if the analysis of human health and ecological effects indicate that no hazard is expected, exposure assessments are not needed because risk would not be anticipated. Please be aware that all hazard endpoints need to be addressed, i.e., ecological hazard as well as cancer and non-cancer hazard endpoints.

Will EPA review my prescreening assessment?
EPA considers all information submitted with every PMN; however, we do not have the resources to review in detail each Sustainable Futures prescreening assessment done by the submitting company. EPA will always conduct an independent review of each PMN.

Can I get a copy of EPA's review of my PMN?
EPA often uses previously submitted PMNs as analogs in the assessment of a new PMN, and as a result the EPA report is CBI and cannot be made public, even to the submitter of the new PMN. Unfortunately, we lack the resources necessary to create sanitized (i.e., non-CBI) summaries of EPA assessments.

Submissions From Companies That Have Graduated

Once a company does graduate, how will EPA reduce the PMN review period from 90 days to 45 days?
EPA is not reducing the review period for a PMN from 90 to 45 days. There will be two concurrent review periods - a 90-day Premanufacture Notice (PMN) review period and a 45-day Test Marketing Exemption Application (TMEA) review period. Once a company graduates, they will be permitted to send in a PMN and a TMEA for the same substance at the same time, i.e., a simultaneous or combined submission of the PMN and TMEA. PMNs and TMEAs have different review periods - 90 days for a PMN and 45 days for a TMEA. When a Graduate submits a combined PMN/TMEA, and if the TMEA is granted, the company is free to begin test marketing manufacture at day 45 under the provisions of the TMEA. Manufacture under a TMEA does not mean the substance would go on the TSCA inventory. When the PMN reaches day 90 and if EPA has not regulated the PMN, the company is free to begin commercial manufacture under the terms of the PMN. If the company made several batches of the substance under test marketing manufacture (between day 45 and day 90), they would be permitted to sell or use the material from those batches until the amount made under test marketing manufacture is gone. Commercial manufacture that may begin after the PMN review period closes on day 90 must take place before a company can submit a notice of commencement (NOC). A company may not use left over material made under the TMEA in submitting an NOC. With the submission of the NOC, the substance that is the subject of the PMN then would be added to the TSCA inventory. The substance won't be added to the Inventory until EPA receives the NOC.

The TMEA component of the combined submission must be a legitimate TME. When the TMEA is submitted, the company must specify (1) the amount of material to be produced and distributed, (2) the number of potential customers to whom it is distributed, and (3) the time period of the test marketing must be specified to EPA in advance of distribution (see http://www.epa.gov/oppt/newchems/pubs/tmeranddbulletin.pdf). EPA does not require a production volume or use limit regarding the TMEA, but the company will be held to the production volume they stated in the TMEA. Therefore, if you need to manufacture 1,000 pounds during the TMEA period for a specialty use, state this in the TMEA. Likewise, if you need to manufacture 1,000,000 pounds for a variety of specific consumer product uses, state that in the TMEA.

We have developed draft language demonstrating the submission is a legitimate TMEA and you are free to model your cover letter after this note. You may modify the language in any way you think is appropriate. A number of companies have used this, or similar, language and the Agency determined that this language demonstrates the application is in fact a legitimate TMEA. The central argument made in the draft language is that because the new substance was developed using risk screening tools at R&D, the substance is unique because risk reduction and/or pollution prevention were considered at R&D, resulting in a potentially unique product that warrants test marketing. The draft language refers to the "P2 Framework" which is the computerized chemical screening models. Sustainable Futures is the programmatic structure EPA uses to deliver the P2 Framework risk screening tools to industry together with training and regulatory relief for qualifying low hazard/low risk PMN submissions.

Submit the customary PMN and add to the cover letter a statement that says you have graduated from Sustainable Futures and that this is a simultaneous PMN/TMEA submission under Sustainable Futures. Your submission will then receive both a PMN and TMEA number.

Do we need to send in two copies of each submission?
Yes, under the electronic PMN system you will need to create and submit two separate notices as the combined Sustainable Futures submission. The electronic PMN system requires each submission to be a unique submission. This means that for Sustainable Futures submissions, the submitter will need to send to EPA two different notices - the PMN and the TMEA. Each submission will have their own Submission Report Number (SRN) which EPA uses for tracking. Using the electronic PMN submission system, the submitter can "create" the TMEA by doing the following: (1) copy the PMN file; (2) renaming the file; (3) open the new file in the e-PMN software; (4) make the changes needed to meet the requirements of a TMEA (note in the cover letter that you are a graduate of Sustainable Futures and that your submission meets the requirements of a TMEA; PMN page 1 mark it as a TMEA submission, PMN page 7 change the production volume as needed, etc); (5) finalize the submission and submit the TMEA.

Can my company also get regulatory relief for Low Volume Exemptions (LVEs)?
The regulatory relief in the form of expedited (45-day) review applies to PMNs, which undergo a 90-day review, and not to LVEs, which undergo a 30-day review.

No one is allowed to submit a LVE (Low Volume Exemption) and a PMN at the same time and only Sustainable Futures Graduates may submit a simultaneous Test Marketing Exemption Application (TMEA) and a PMN for the same chemical at the same time, but not a combined LVE/PMN.

After a Graduate submits a combined PMN/TMEA and day 45 of the TMEA has been reached with no EPA objection/regulation will the company be notified that they will be able to commence commercial manufacture of their PMN substance?
If and when the TMEA portion of the combined PMN/TMEA is granted and the PMN is dropped during the first 30 days of review, you will be notified by EPA's Sustainable Futures staff and/or staff in the OPPT Chemical Control Division. The email or phone call from the SF staff will most likely be from Maggie Johnson or Kelly Mayo. You will be contacted by EPA staff in the OPPT Chemical Control Division if either the TMEA is not granted or the PMN is not dropped during the first 30 days of review. When you submit your combined PMN/TMEA, please email Maggie Johnson (johnson.maggie@epa.gov) or Kelly Mayo (mayo.kelly@epa.gov) to let the SF staff know it is coming and tell them who should be contacted if and when the TMEA is granted and the PMN is dropped during review.

When the TMEA portion (of a PMN/TMEA submission) is approved the SF Graduate will be able to commence manufacture for test marketing purposes as stipulated by the TMEA, but will not be able to commence manufacture for commercial purposes until day 90, as long as the Agency takes no action on the PMN portion of a combined PMN/TMEA. The PMN component of the simultaneous submission will still receive the normal 90-day PMN review period just like all other PMNs. If EPA grants the TMEA, but does not drop the PMN during the first 30 days of review, the submitter will be notified that they must choose, by letter within 15 days of being notified of the Agency's decision, to continue only one of the two notification procedures (i.e., withdraw the TMEA and continue with the PMN, or continue with the TMEA and withdraw the PMN).

Top of Page

PBT Profiler

Does EPA keep a record of the chemicals I evaluate using the PBT Profiler?
No user identification, chemical information, screening results, or any other electronic information entered into or generated by the PBT Profiler are intentionally tracked, stored, or collected. Information on user anonymity and security is provided on the PBT Profiler Web site Exit EPA Disclaimer.

Can I get a copy of the PBT Profiler as a stand-alone method like EPI Suite?
The PBT Profiler will not be available as a stand-alone method. The supporting modules and databases behind the PBT Profiler are routinely updated by Syracuse Research Corporation. If the model were a stand-alone there could eventually be multiple versions of the method in use, and this can create confusion. EPA prefers that the same version of the PBT Profiler be available to all users.

Will the PBT Profiler have a batch mode capability?
For an online method like the PBT Profiler to have a batch mode capacity would require that files be written to the server on which the method resides. Due to users' security concerns it was decided that the PBT Profiler would not have a batch mode capacity.

Top of Page

Local Navigation

Jump to main content.